The Effect on Anxiolytics With Type of Antiemetic Agents on Postoperative Nausea and Vomiting in High Risk Patients

Completed

• Conditions: Postoperative Nausea and Vomiting

• Registration Number: NCT04466046
• Lead Sponsor: Daegu Catholic University Medical Center

Brief Summary

Nausea and vomiting after surgery are one of the complications that occur after general anesthesia, and the frequency is reported to range from 10% to 80% in the high-risk group. Several studies have introduced drugs and methods to prevent nausea and vomiting after surgery. Among them, midazolam administered before surgery is known to have anti-anxiolytic and sedative effects on the prevention of nausea and vomiting after surgery. It has also been reported to increase its effectiveness when administered with other antiemetic agents.

The purpose of this study is to compare the effects of administration of combination with midazolam and different antiemetic agents on the prevention of postoperative nausea and vomiting in high-risk patients.

Detailed Description

This prospective study evaluates female, nonsmoking patients undergoing laparoscopic cholecystectomy. The patients are divided into those with and without postoperative nausea and vomiting. The purpose of this study is to compare and observe the effect of administration of midazolam and two different antiemetics on prevention of postoperative nausea and vomiting.

0.05mg/kg of midazolam is administered intravenously 10 minutes before surgery as a pretreatment. 0.3mg ramosetron is administered intravenously right before the end of surgery and 0.075mg palonosetron is administered intravenously immediately after induction of anesthesia. The incidence of PONV, severity of nausea, use of rescue antiemetics, and pain severity was evaluated at 2 hours, 24hours, and 48 hours after surgery.

Study Timeline

• Study Start: 2019-09-04
• Primary Completion: 2020-06-30
• Study Completion: 2020-06-30
• Study First Submitted: 2020-07-02
• Study First Submitted QC: 2020-07-07
• Study First Posted: 2020-07-10
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-31
• Last Update Posted: 2022-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 68

Inclusion Criteria

• 20-65 years old with American Society of Anesthesiologists (ASA) physical status 1-2 and scheduled for laparoscopic cholecystectomy.

Exclusion Criteria

• pregnant or breast feeding patients
• smokers
• patients with history of chronic opioid abuse
• hypersensitivity to 5-HT3 receptor antagonists or analgesics
• those who were antiemetic or opioid treatment within 24 hours prior to surgery

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
percentage of patients receiving ramosetron or palonosetron in each groups	48 hours after surgery	percentage of patients receiving ramosetron or palonosetron
severity of postoperative nausea in PONV group	48 hours after surgery	0 = none, 1 = mild, 2 = moderate, 3 = severe

Secondary Outcome Measures

Name	Time	Method
postoperative pain	48 hours after surgery	numerical analog scale : 0 to 10

Trial Locations

Locations (1)

Daegu Catholic University Medical Center; 🇰🇷 Daegu, Nam-gu, Korea, Republic of